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Dual Sympathetic Blocks for Patients Experiencing Sympathetically-Mediated Symptoms From Long COVID (DSBLongCOVID)

Primary Purpose

Post Acute COVID-19 Syndrome, Long COVID, Long Covid19

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
stellate ganglion block with 0.5% bupivacaine
Sponsored by
Jonathann Kuo, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Acute COVID-19 Syndrome focused on measuring COVID, long covid, SARS-COV2, COVID-19, long COVID-19, post covid, dysautonomia, stellate ganglion block, dual sympathetic block, SGB, DSB

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing Persistent symptoms that continue four or more weeks after the start of a COVID-19 infection Quantified autonomic symptoms from at least one domain as reported by the patient on the screener Composite Autonomic Symptom Score (COMPASS-31). The COMPASS-31 assesses 6 domains of autonomic symptoms: Orthostatic Intolerance, Vasomotor, Secretomotor, Gastrointestinal, Bladder, and Pupillomotor. Quantified pain symptoms of pain interference or pain intensity as reported by the patient on the screener Patient-Reported Outcomes Measurement Information System (PROMIS-29) Exclusion Criteria: Under age 18 Prior SGB Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine/Marcaine) Pregnancy Current anticoagulant use History of a bleeding disorder History of glaucoma Infection or mass at injection site For the consistency of this study, patients who deny all autonomic symptoms on the COMPASS-31 or pain symptoms on the PROMIS-29 will also be excluded

Sites / Locations

  • Hudson Medical

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

This is a non-randomized, non-blinded study. Participants eligible for this study will receive active treatment. Dual Sympathetic Blocks of the stellate ganglion are minimally- invasive outpatient procedures performed under monitored care anesthesia (light sedation). Under ultrasound visualization, a small needle is guided into the neck region that contains the stellate ganglion nerve cluster at C6-C7. Once the needle position is confirmed, a local anesthetic (7 cc of 0.5% bupivacaine/Marcaine) is injected around the stellate ganglion by the Principal Investigator. This procedure is repeated at the C3-C4 level to block the superior cervical ganglion nerve cluster (3 cc of 0.5% bupivacaine/Marcaine).

Outcomes

Primary Outcome Measures

Patient-Reported Outcomes: PROMIS-29 Score
The primary objective of the clinical effectiveness trial is to evaluate whether Dual Sympathetic Blocks performed at 0 and 1 weeks will improve patient-reported outcomes of depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities status. These domains are measured as reflected by Patient-Reported Outcomes Measurement Information System (PROMIS-29) total scores between baseline and 4 weeks
Depression
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Anxiety
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Physical function
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Pain interference
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Fatigue
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Sleep disturbance
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Ability to participate in social roles and activities status
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.

Secondary Outcome Measures

Autonomic Symptoms: COMPASS-31 Score
The secondary objective of the clinical effectiveness trial is to evaluate whether Dual Sympathetic Blocks performed at 0 and 1 weeks will improve Dysautonomia symptoms as reflected by corresponding Composite Autonomic Symptom Scale 31 (COMPASS-31) scores between baseline and 4 weeks

Full Information

First Posted
November 22, 2022
Last Updated
September 25, 2023
Sponsor
Jonathann Kuo, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05638620
Brief Title
Dual Sympathetic Blocks for Patients Experiencing Sympathetically-Mediated Symptoms From Long COVID
Acronym
DSBLongCOVID
Official Title
Evaluating the Effectiveness of Dual Sympathetic Blocks for Patients Experiencing Sympathetically-Mediated Symptoms From Post-Acute Sequelae of SARS-CoV-2 (PASC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jonathann Kuo, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The main purpose of this study is to gather data and assess changes in patient-reported outcomes with the stellate ganglion blocks as treatment for their sympathetically-mediated long COVID symptoms.
Detailed Description
1.1 Background 1.1.1.Post-Acute Sequelae of SARS-CoV-2 (PASC) Since the onset of the COVID-19 pandemic, demands for rapid mobilization of research initiatives and treatment protocols continue to grow. While some people recover quickly from COVID-19, an increasing number of individuals previously infected with the SARS-CoV-2 virus report experiencing new, returning, or ongoing health problems long after recovery from the acute disease.The CDC and NIH define these long-term effects of COVID-19 by the broad research term Post-Acute Sequelae of SARS-CoV-2 infection (PASC), which is characterized by the presence of persistent or recurrent symptoms in patients who have recovered from an acute SARS-CoV-2 infection. PASC, also known as post-COVID conditions (PCC) or long COVID, presents in different ways and can affect the function of many different organs and systems including respiratory, neurological, and digestive systems. Most commonly, PASC symptoms include fatigue, post-exertional malaise, shortness of breath, "brain fog," sleep problems, fever, anxiety, and depression. Other symptoms include persistent cough, chest pain or chest discomfort, headache, heart palpitations, joint or muscle pain, diarrhea, nausea, abdominal pain, fever, dizziness, anosmia, or ageusia. Symptoms can vary between patients as some will experience only one of these symptoms while others may have two or more. The severity of symptoms range from mild to severe and can be debilitating. There is no test to diagnose post-COVID conditions. The symptoms of PASC can be difficult to explain and clinical evaluations or testing from routine blood tests, chest x- rays, and electrocardiograms may be normal, making it difficult for healthcare providers to recognize. Though more prevalent in people who had severe COVID-19 illness, anyone who has been infected with the virus that causes COVID-19 can experience post-COVID conditions, even people who had mild illness or no symptoms from a SARS- CoV-2 infection. Healthcare providers consider a diagnosis of post-COVID conditions based on a patient's health history, including if they had a diagnosis of COVID-19 either by a positive test or by symptoms or exposure. PASC can have significant effects beyond managing the physical symptoms. Many people report that long COVID symptoms prevent them from returning to work or school or cause them difficulties in performing everyday tasks or even walking short distances. Pain centers seeing patients with PASC report most patients would meet the definition of chronic primary pain with major distress based on the ICD-11 chapter for chronic pain (Wadehra). Furthermore, recent guidance states PASC, or Long COVID, can qualify as a disability under the American Disability Act if it limits at least one major life activity. The current research and understanding of PASC indicates it acts similarly to syndromes of chronic pain and sympathetic nervous system dysfunction that may be targeted by existing interventions. The symptoms can be functionally debilitating and can severely diminish quality of life, so identifying effective treatments and management strategies that address this disease may prove to have significant implications in the wake of the COVID-19 Pandemic. 1.1.2. Treatment for Post-Acute Sequelae of SARS-CoV-2 (PASC) As PASC has only recently been defined as a distinct disease state, it is not well understood yet and targeted and effective treatment options are extremely limited. PASC can affect many different organ systems, so current treatments are often multi- disciplinary, focusing on symptomatic management and treatment of underlying health problems. Clinicians have suggested that effective treatment should manage related pain and dysfunction. Many PASC symptoms that fail to respond to traditional treatment protocols are associated with dysautonomia. Dysautonomia is abnormal activity of involuntary body functions that are regulated by the sympathetic nervous system, such as heart rate, breathing and digestion. Sympathetic innervation plays a vital role in the communication between the immune system and the nervous system, but pathologies, such as elevated cytokine levels, can disrupt this relationship and promote sympathetic responses and subsequent inflammatory problems. In this way, the well-documented cytokine storm response to a SARS-CoV-2 infection results from sympathetic activation as the autonomic nervous system responds to pro-inflammatory cytokines. During elevated sympathetic signaling, the brainstem responds by integrating this information into "sickness behaviors," a set of behavioral responses which closely resembles PASC symptoms. As PASC may persist over weeks or months, persistent dysfunctional or inappropriate sympathetic signaling may potentially contribute to or exacerbate symptoms. Furthermore, prolonged dysautonomia is associated with impaired cerebral blood flow (CBF) in conditions such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), postural orthostatic tachycardia syndrome (POTS), and other poorly understood sympathetically-mediated chronic illnesses like complex regional pain syndrome (CRPS). In general, impaired CBF causes a range of clinical symptoms such as cognitive dysfunction, impaired memory and attention, and reduced visual, gustatory or olfactory function. The clinical presentations in these conditions parallel many common symptoms of PASC. Ongoing research and case studies are working to better understand the pathophysiology and effective treatments for PASC. The purpose of this study is to identify patients with continued hyperactivation of the sympathetic nervous system that can be targeted with existing treatments. A cases series conducted in 2021 showed promising results supporting Stellate ganglion blocks to reduce symptoms of Long COVID, or PASC. The case series reported sustained positive clinical outcomes for two Long COVID patients after treatment with SGB, identifying the pathophysiology for their symptoms as a regional sympathetically mediated dysautonomia. The results suggest SGB could be an effective intervention for at least a subset of Long COVID patients. Researchers conclude that although the application of SGB in PASC is novel, it is a promising and attractive therapeutic for a condition that currently lacks effective treatment options. 1.1.3. Dual Sympathetic Blocks (Stellate Ganglion Blocks) Sympathetic nerve blocks are established procedures used by many pain management providers as an effective method to diagnose or treat pain involving the nerves of the sympathetic nervous system. A block of the sympathetic nerves at the Stellate Ganglion in the upper neck has been used for decades to treat complex, sympathetically-mediated pain syndromes affecting the head, face, neck and arms. The stellate ganglion nerve bundle carries sympathetic signaling to many body regions and organs, including the head, neck, upper limbs, thymus, heart, lungs, lacrimal gland, salivary gland, thyroid gland and pineal gland. Injection of local anesthetic near the stellate ganglion can block activity of the entire cervical sympathetic chain, as evidenced by the physiological signs of a successful stellate ganglion block (SGB) collectively known as "Horner's Syndrome" which includes ipsilateral ptosis, meiosis, anhidrosis, and facial flushing. Researchers suggest the SGB can alleviate symptoms of dysautonomia by providing local recalibration of regional sympathetic influence, central integration of the effects of increased CBF, or rebalancing of the interaction between the nervous and immune systems. During the procedure, a physician uses x-ray or ultrasound imaging to guide a needle into a bundle of nerves located near the base of the neck. The physician then injects a local anesthetic into the nerve tissue like a dentist delivers numbing medicine before a dental procedure. The anesthetic lasts only a few hours, but the effects of the procedure can last for several weeks or longer in some cases. The use of Marcaine (bupivacaine) is indicated for local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures (including sympathetic nerve blocks), and for obstetrical procedures. The drug is lawfully marketed as a prescription drug product, and this investigation is not intended to support a significant change in the advertising for the product. There is increasing evidence that PASC has a similar profile to many pain syndromes, and dysautonomia appears to play an important role among the clinical manifestations in both the acute and chronic phase of SARS-CoV-2 infection. Thus, the use of sympathetic blocks in this study is meant to be included under the current indications for the treatment: an effective method to diagnose or treat pain involving the nerves of the sympathetic nervous system. 1.1.4. Theoretical Models There are a few published case series that seek to make further connections between PASC symptoms and autonomic dysfunction. Researchers express that the safety profile for Dual Sympathetic Blocks (Stellate ganglion blocks) is well established and has been used for nearly a century to treat a variety of sympathetically-mediated medical conditions. The lack of effective treatments for Long COVID/PASC makes the DSB an attractive therapeutic modality that deserves further investigation. 1.2 Rationale for Current Study This investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug. Clinicians have suggested that effective treatment for PASC should manage related pain and dysfunction. A sympathetic nerve block is used to both diagnose dysfunction and treat pain caused by the sympathetic nervous system. Sympathetic nerve blocks including the stellate ganglion blocks have been widely used by pain management physicians and their safety is well proven for the treatment of sympathetically-mediated pain syndromes. Though PASC has only recently been defined, emerging and continued research supports the understanding that the SARS-CoV-2 infection affects the autonomic nervous system. Therefore, this study hopes to analyze the effectiveness of sympathetic nerve blocks to identify and treat symptoms of sympathetically-mediated pain or dysfunction in patients with PASC. The propensity of the PASC to lead to long-term illness and impairments calls for clinical trials aimed at prevention and treatment. The PROMIS-29 and COMPASS-31 surveys will be administered as part of the screening process to identify autonomic dysfunction. Patients who report symptoms of pain that interferes with daily function and at least one autonomic symptom that recurs or persists for 4 weeks or more after a SARS-CoV-2 infection meet the current criteria for PASC and may be eligible to participate. Findings from the current study may provide much needed insight into the state of the PASC disease and guidance for future clinical studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Acute COVID-19 Syndrome, Long COVID, Long Covid19, COVID-19 Recurrent, Post-Acute COVID-19, Post-Acute COVID-19 Infection, SARS-CoV2 Infection, Post Acute Sequelae of COVID-19, Dysautonomia, Dysautonomia Like Disorder, Dysautonomia Orthostatic Hypotension Syndrome, Post COVID-19 Condition, Post-COVID Syndrome, Post COVID-19 Condition, Unspecified, Post-COVID-19 Syndrome
Keywords
COVID, long covid, SARS-COV2, COVID-19, long COVID-19, post covid, dysautonomia, stellate ganglion block, dual sympathetic block, SGB, DSB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
This will be a single-site, non-randomized, open-label, prospective study to evaluate the effects of bilateral Dual Sympathetic Blocks (DSB) on the dysautonomic symptomatology of Post-Acute Sequelae of SARS-CoV-2 (PASC). Patients will be evaluated for pain interference and dysautonomic symptomatology by the PROMIS-29 and COMPASS-31 scores at 0,1, and 4 weeks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
This is a non-randomized, non-blinded study. Participants eligible for this study will receive active treatment. Dual Sympathetic Blocks of the stellate ganglion are minimally- invasive outpatient procedures performed under monitored care anesthesia (light sedation). Under ultrasound visualization, a small needle is guided into the neck region that contains the stellate ganglion nerve cluster at C6-C7. Once the needle position is confirmed, a local anesthetic (7 cc of 0.5% bupivacaine/Marcaine) is injected around the stellate ganglion by the Principal Investigator. This procedure is repeated at the C3-C4 level to block the superior cervical ganglion nerve cluster (3 cc of 0.5% bupivacaine/Marcaine).
Intervention Type
Drug
Intervention Name(s)
stellate ganglion block with 0.5% bupivacaine
Other Intervention Name(s)
Dual Sympathetic Block, Stellate ganglion nerve block
Intervention Description
The stellate ganglion block is being done on both sides of the neck. The stellate ganglion block will be performed on the right side at the first visit. The procedure will be repeated on the left side one week after the first injection. This study is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug. Similar to a phase 1 clinical trial, the main purpose of this study is to gather data and assess changes in patient-reported outcomes with the stellate ganglion blocks as treatment for their sympathetically-mediated long COVID symptoms. As a general rule, phase 1 studies require a low number of patients, typically 12-20 subjects. There is considerable uncertainty regarding long COVID as a disease state, so data from even small numbers of patients in a well-designed clinical trial will make steps towards reducing that uncertainty.
Primary Outcome Measure Information:
Title
Patient-Reported Outcomes: PROMIS-29 Score
Description
The primary objective of the clinical effectiveness trial is to evaluate whether Dual Sympathetic Blocks performed at 0 and 1 weeks will improve patient-reported outcomes of depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities status. These domains are measured as reflected by Patient-Reported Outcomes Measurement Information System (PROMIS-29) total scores between baseline and 4 weeks
Time Frame
1 month
Title
Depression
Description
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Time Frame
1 month
Title
Anxiety
Description
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Time Frame
1 month
Title
Physical function
Description
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Time Frame
1 month
Title
Pain interference
Description
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Time Frame
1 month
Title
Fatigue
Description
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Time Frame
1 month
Title
Sleep disturbance
Description
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Time Frame
1 month
Title
Ability to participate in social roles and activities status
Description
PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Autonomic Symptoms: COMPASS-31 Score
Description
The secondary objective of the clinical effectiveness trial is to evaluate whether Dual Sympathetic Blocks performed at 0 and 1 weeks will improve Dysautonomia symptoms as reflected by corresponding Composite Autonomic Symptom Scale 31 (COMPASS-31) scores between baseline and 4 weeks
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing Persistent symptoms that continue four or more weeks after the start of a COVID-19 infection Quantified autonomic symptoms from at least one domain as reported by the patient on the screener Composite Autonomic Symptom Score (COMPASS-31). The COMPASS-31 assesses 6 domains of autonomic symptoms: Orthostatic Intolerance, Vasomotor, Secretomotor, Gastrointestinal, Bladder, and Pupillomotor. Quantified pain symptoms of pain interference or pain intensity as reported by the patient on the screener Patient-Reported Outcomes Measurement Information System (PROMIS-29) Exclusion Criteria: Under age 18 Prior SGB Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine/Marcaine) Pregnancy Current anticoagulant use History of a bleeding disorder History of glaucoma Infection or mass at injection site For the consistency of this study, patients who deny all autonomic symptoms on the COMPASS-31 or pain symptoms on the PROMIS-29 will also be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathann Kuo, MD
Organizational Affiliation
Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hudson Medical
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All information will be kept confidential. Study-related information will be stored securely at the study site. All participant information will be stored with limited access. All reports, data collection, and administrative forms will be identified by a coded ID [identification] number only to maintain participant confidentiality. Records that contain names or other personal identifiers, such as locator forms and informed consent forms, will be stored separately from study records identified by code number. All local databases will be secured with password-protected access systems. Forms, lists, logbooks, appointment books, and any other listings that link participant ID numbers to other identifying information will be stored in a separate, locked file with limited access.
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Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS). ClinicaTrials.gov identifier NCT04402840. Updated November 3, 2020. Accessed October 11, 2022.

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Dual Sympathetic Blocks for Patients Experiencing Sympathetically-Mediated Symptoms From Long COVID

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